赤丹退黄颗粒治疗急慢性病毒性淤胆型肝炎的开放对照研究

Open Comparative Study of Chidan Tuihuang Granule in Treating Acute and Chronic Viral Cholestatic Hepatitis

目的:评价赤丹退黄颗粒对辨证为瘀热发黄的急慢性病毒性淤胆型肝炎消退黄疸的安全性和有效性。方法:采用前瞻性多中心随机开放对照试验,416例患者按3:1比例分为两组,分别用赤丹退黄颗粒(治疗组312例)及加诺片(对照组104例)治疗,疗程均为8周,并进行近、远期疗效随访。结果:治疗组降低血清总胆红素水平、退黄显效率及总有效率均优于对照组(P<0.05或P<0.01);随访结果提示赤丹退黄颗粒有较稳定的远期疗效,不良事件发生率两组比较差异无显著性。结论:赤丹退黄颗粒是治疗瘀热发黄所致的急慢性病毒性淤胆型肝炎安全、有效的药物。

Objective: To evaluate the efficacy and safety of Chidan Tuihuang Granule (CTG) in treating acute and chronic viral cholestatic hepatitis of TCM Heat-stagnant jaundice type. Methods:The 416 patients, adopting the open perspective multi-centered randomized controlled clinical trial, were randomly divided in the ratio of 3: 1 into the CTG group ( n - 312) and the control group ( n = 104, treated with Galle-Donau tablet) . The therapeutic course to both groups was 8 weeks and follow-up study, both short-term and long-term, were conducted. Results: The CTG treatment was superior to the control in serum total bilirubin value lowering, effective rate and total effective rate of jaundice eliminating. Long-term follow-up study showed that CTG had a better and stable effect, and the incidence rate of adverse event in the two groups was not different significantly. Conclusion: CTG is a safe and effective drug in treating acute and chronic viral cholestatic hepatitis of TCM Heat-stagnant jaundice type.